Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
|
|
- Emma Walker
- 5 years ago
- Views:
Transcription
1 DRUG NAME: Megestrol SYNONYM(S): megestrol acetate 1 COMMON TRADE NAME(S): APO-MEGESTROL, MEGACE, MEGACE OS, NU-MEGESTROL, MEGACE ES (USA) CLASSIFICATION: hormonal agent Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM OF ACTION: A synthetic progestin with the same physiologic effects as progesterone. 1,2 Though its precise antineoplastic mechanism is unknown, megestrol is thought to act by suppressing release of luteinizing hormone from the pituitary gland or by a direct effect on cancer cells. 1-3 Megestrol has slight glucocorticoid activity and a very slight degree of mineralocorticoid activity. 2 Megestrol may also have antiandrogen activity, suppress adrenal androgens, and inhibit the enzyme 5 α reductase. 1 PHARMACOKINETICS: Oral Absorption Distribution Metabolism Excretion variable, time to peak 1,2 : 1-5 h cross blood brain barrier? volume of distribution plasma protein binding 4 high inactivated in intestine and liver to free steroids and glucuronide conjugates active metabolite(s) inactive metabolite(s) yes respiratory excretion and fat storage may also occur urine 66% (range: 57-78%) feces 20% (range: 8-30%) terminal half life h; dose-dependent, mg: 3.5 d, 160 mg: 38 h clearance Adapted from standard reference 1 unless specified otherwise. USES: Primary uses: *Breast cancer *Endometrial cancer *Health Canada approved indication Other uses: *Cancer cachexia *Prostate cancer SPECIAL PRECAUTIONS: Caution: history of thrombophlebitis 1 adrenocortical insufficiency 1 ; see paragraph following the Side Effects table diabetes (due to risk of hyperglycemia) 5 BC Cancer Agency Cancer Drug Manual Page 1 of 5 Megestrol
2 should not be used as a diagnostic test for pregnancy 1 HIV infected women (due to risk of breakthrough bleeding) 1 should not be used prophylactically to avoid weight loss 5 Carcinogenicity: An increased incidence of benign and malignant breast tumours has been reported in female dogs treated for up to seven years; an increased incidence has not been noted in monkeys when treated for up to ten years. 1 Dogs treated with times the human dose, on a mg/kg basis, have developed mammary carcinoma with metastasis. 1 Pituitary tumours have occurred in female rats treated for 2 years. 1 Malignant lymphoma in mice may be stimulated. 1 The relevance of these findings to humans has not been established. 1 Mutagenicity: studies not performed to date 1,2 Fertility: In monkeys, megestrol caused decreased mean uterine weights and estrogen activity and a dose-related reduction in menses with near cessation of cyclic activity at 5 times the human dose on a mg/kg basis. 1 Impaired fertility in male offspring of female rats and dogs receiving doses equivalent to less than the recommended human dose has also been reported. 1,2 No information has been found regarding fertility in male animals. 2 Pregnancy: FDA Pregnancy Category X. 3 Studies in animals or humans have shown fetal abnormalities, 1 or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. Breastfeeding is not recommended due to the potential secretion into breast milk. 1 SIDE EFFECTS: The table includes adverse events that presented during drug treatment but may not necessarily have a causal relationship with the drug. Because clinical trials are conducted under very specific conditions, the adverse event rates observed may not reflect the rates observed in clinical practice. Adverse events are generally included if they were reported in more than 1% of patients in the product monograph or pivotal trials, and/or determined to be clinically important. 6 ORGAN SITE SIDE EFFECT Clinically important side effects are in bold, italics Side effects and incidence are those when used for cancer treatment, cancer cachexia information is not included. Megestrol is usually well tolerated. 2 auditory/hearing cardiovascular (general) constitutional symptoms hearing loss heart failure; typically mild and resolves with initiation of diuretic therapy or adjustment of antihypertensive regimen 2 hypertension; typically occurs with high-doses ( mg), 2 typically mild and resolves with initiation of diuretic therapy or adjustment of antihypertensive regimen 2 fatigue 5 hot flashes weight gain (1-33%) 1,2 ; associated with increased appetite, may be dose-related 2 dermatology/skin alopecia rash endocrine adrenal insufficiency (<1%); see paragraph following Side Effects table cushingoid appearance gastrointestinal emetogenic potential: rare 7 nausea and vomiting (1-7%) 1,2,8 BC Cancer Agency Cancer Drug Manual Page 2 of 5 Megestrol
3 ORGAN SITE SIDE EFFECT Clinically important side effects are in bold, italics Side effects and incidence are those when used for cancer treatment, cancer cachexia information is not included. Megestrol is usually well tolerated. 2 hemorrhage vaginal bleeding (1-2%); including breakthrough and withdrawal 2,9 bleeding lymphatics edema (1-2%) metabolic/laboratory hypercalcemia; secondary to tumour flare, in patients with bone metastases 9 hyperglycemia; including new onset diabetes and exacerbation of preexisting diabetes 5 ; secondary to pituitary adrenal axis abnormalities 5 laboratory evidence of pituitary-adrenal axis abnormalities neurology depression 8 mood changes/swings 9 pulmonary dyspnea (1-3%) 2 sexual/reproductive function gynecomastia 2 impotence 5 syndromes carpal tunnel syndrome Cushing s syndrome 5 tumour flare; with and without hypercalcemia vascular thrombosis/embolism; deaths have occurred Adapted from standard reference 1 unless specified otherwise. Adrenal insufficiency: Megestrol may rarely suppress the pituitary-adrenal axis during chronic administration. 1 Glucose intolerance, new onset diabetes, exacerbation of preexisting diabetes, and Cushing s syndrome have been reported. 5 Consider the possibility of adrenal insufficiency in patients being withdrawn from chronic therapy. 1 Symptoms may include fatigue, anorexia, hypotension, and asthenia. 10 Replacement therapy with a rapid-acting glucocorticoid should be considered. 3 INTERACTIONS: AGENT EFFECT MECHANISM MANAGEMENT rifabutin 11 zidovudine 11 no documented effect on megestrol pharmacokinetics no documented effect on megestrol pharmacokinetics SUPPLY AND STORAGE: Tablets: Apotex and Bristol-Myers Squibb supply megestrol as 40 mg and 160 mg scored tablets. Selected nonmedicinal ingredients: lactose. 1,5 Store at room temperature. 1,5 BC Cancer Agency Cancer Drug Manual Page 3 of 5 Megestrol
4 Additional information: Bristol-Myers Squibb supplies megestrol as a 240 ml bottle of 40 mg/ml suspension (only indicated for the treatment of anorexia in patients with a diagnosis of acquired immunodeficiency syndrome). 5 MEGACE ES 125 mg/ml (USA) is not equivalent on a mg per mg basis with other megestrol formulations due to its increased bioavailability 2,9 (625 mg MEGACE ES is equivalent to 800 mg megestrol tablets or suspension). DOSAGE GUIDELINES: Refer to protocol by which patient is being treated. Adults: BCCA usual dose noted in bold, italics 160 mg or 125 mg/m 2 (range mg) 3 PO once daily 1,2,12 dose may be divided into four doses a day mg (range mg) or mg/m 2 PO once daily 1,2,12 dose may be divided into four doses a day mg (range mg) PO once daily 1,2 for the treatment of cancer cachexia Concurrent radiation: dosage adjustment not required 6 Dosage in renal failure: Dosage in hepatic failure: Dosage in dialysis: it is not known if megestrol is removed by dialysis; due to low solubility it is unlikely to be removed by dialysis 1 Children: safety and effectiveness in children not established 1 ; has been used 13 REFERENCES: 1. Apotex Inc. Apo-Megestrol Product Monograph. Weston, Ontario; 18 June McEvoy GK, editor. AHFS 2007 Drug Information. Bethesda, Maryland: American Society of Health-System Pharmacists, Inc. p Rose BD editor. Megestrol acetate. UpToDate 15.2 ed. Waltham, Massachusetts: UpToDate ; MARTINDALE- The Complete Drug Reference (database on the Internet). Megestrol acetate. Thomson MICROMEDEX, Available at: Accessed 24 September Bristol-Myers Squibb Canada Inc. MEGACE AND MEGACE OS Product Monograph. Cote de Liesse Rd, Montreal; 22 September Nicol Macpherson MD. Personal communication. BC Cancer Agency Breast Tumour Group; 17 December BC Cancer Agency. (SCNAUSEA) Guidelines for Prevention and Treatment of Chemotherapy-induced Nausea and Vomiting in Adults. Vancouver, British Columbia: BC Cancer Agency; 1 November Solimando Jr DA. Aminoglutethimide and megestrol. Hospital Pharmacy 1999;34(3): DRUGDEX Evaluations (database on the Internet). Megestrol. Thomson MICROMEDEX, Available at: Accessed 24 September Rose BD editor. Diagnosis of adrenal insufficiency in adults. UpToDate 15.3 ed. Waltham, Massachusetts: UpToDate ; BC Cancer Agency Cancer Drug Manual Page 4 of 5 Megestrol
5 11. Drug Interaction Facts (database on the Internet). Megestrol acetate monograph. Facts and Comparisons 4.0, Available at: Accessed 24 August BC Cancer Agency Breast Tumour Group. (BRAVMEG) BCCA Protocol Summary for Palliative Therapy for Advanced Breast Cancer Using Megestrol. Vancouver, British Columbia: BC Cancer Agency; 1 December Azcona C, Castro L, Crespo E, et al. Megestrol acetate therapy for anorexia and weight loss in children with malignant solid tumours. Aliment.Pharmacol.Ther. 1996;10(4): BC Cancer Agency Cancer Drug Manual Page 5 of 5 Megestrol
Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Lomustine SYNONYM(S): CCNU 1 COMMON TRADE NAME(S): CeeNU CLASSIFICATION: alkylating agent Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM
More informationDRUG NAME: Nilutamide
DRUG NAME: Nilutamide SYNONYM(S): COMMON TRADE NAME(S): ANANDRON CLASSIFICATION: hormonal agent Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM OF
More informationDRUG NAME: Bromocriptine
DRUG NAME: Bromocriptine SYNONYM(S): COMMON TRADE NAME(S): APO-BROMOCRIPTINE, PMS-BROMOCRIPTINE CLASSIFICATION: hormonal agent Special pediatric considerations are noted when applicable, otherwise adult
More informationDRUG NAME: Cabergoline
DRUG NAME: Cabergoline SYNONYM(S): COMMON TRADE NAME(S): DOSTINEX CLASSIFICATION: hormonal agent Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM
More informationDRUG NAME: Palbociclib
DRUG NAME: Palbociclib SYNONYM(S): PD 0332991; PD 991; PF 332991 1 COMMON TRADE NAME(S): IBRANCE CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise
More informationDRUG NAME: Palbociclib
DRUG NAME: Palbociclib SYNONYM(S): PD 0332991; PD 991; PF 332991 1 COMMON TRADE NAME(S): IBRANCE CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise
More informationDRUG NAME: Ruxolitinib
DRUG NAME: Ruxolitinib SYNONYM(S): ruxolitinib phosphate, 1 INCB018424 2 COMMON TRADE NAME(S): JAKAVI, 3 JAKAFI (USA) 1 CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable,
More informationDRUG NAME: Lanreotide
DRUG NAME: Lanreotide SYNONYM(S): lanreotide acetate, 1 SOMATULINE AUTOGEL, 1 SOMATULINE DEPOT 2,3 COMMON TRADE NAME(S): SOMATULINE CLASSIFICATION: synthetic somatostatin analogue Special pediatric considerations
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Degarelix SYNONYM(S): degarelix acetate COMMON TRADE NAME(S): FIRMAGON CLASSIFICATION: hormonal agent Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
More informationDRUG NAME: Streptozocin
DRUG NAME: Streptozocin SYNONYM(S): Streptozotocin 1 COMMON TRADE NAME(S): ZANOSAR CLASSIFICATION: alkylating agent-antitumour antibiotic, cytotoxic 2 Special pediatric considerations are noted when applicable,
More informationDRUG NAME: Aldesleukin
DRUG NAME: Aldesleukin SYNONYM(S) 1 : Interleukin-2, IL-2 COMMON TRADE NAME(S): PROLEUKIN CLASSIFICATION: biological response modifier Special pediatric considerations are noted when applicable, otherwise
More informationDRUG NAME: Estramustine
DRUG NAME: Estramustine SYNONYM(S): Estramustine sodium phosphate, 1 EMP 1,2 COMMON TRADE NAME(S): EMCYT CLASSIFICATION: alkylating agent Special pediatric considerations are noted when applicable, otherwise
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Gefitinib SYNONYM(S): ZD1839 COMMON TRADE NAME(S): IRESSA CLASSIFICATION: epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor Special pediatric considerations are noted when applicable,
More informationPATIENT MEDICATION INFORMATION. MEGACE OS Megestrol acetate Oral Suspension
PATIENT MEDICATION INFORMATION MEGACE OS Megestrol acetate Oral Suspension Read this carefully before you start taking MEGACE OS and each time you get a refill. This leaflet is a summary and will not tell
More informationDRUG NAME: Paclitaxel, nanoparticle, albumin-bound (nab)
DRUG NAME: Paclitaxel, nanoparticle, albumin-bound (nab) SYNONYM(S): protein-bound paclitaxel 1, nab-paclitaxel COMMON TRADE NAME(S): ABRAXANE CLASSIFICATION: antimicrotubule agent Special pediatric considerations
More informationDRUG NAME: Plerixafor
DRUG NAME: Plerixafor SYNONYM(S): AMD3100 1 COMMON TRADE NAME(S): MOZOBIL CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise adult provisions
More informationSee 17 for PATIENT COUNSELING INFORMATION. Revised 01/2016
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MEGACE ES safely and effectively. See full prescribing information for MEGACE ES. MEGACE ES (megestrol
More informationDRUG NAME: Ramucirumab
DRUG NAME: Ramucirumab SYNONYM(S): IMC-1121B 1 COMMON TRADE NAME(S): CYRAMZA CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise adult provisions
More informationAbiraterone Acetate is an antiandrogen used in the treatment of Castration-Resistant Prostate Cancer(CRPC).
For the use only of an Oncologist or a Hospital or a Laboratory ABIRATERONE ACETATE TABLETS Zabiteron-250 COMPOSITION Abiraterone Acetate Tablets 250mg Each uncoated tablets contains: Abiraterone Acetate
More informationDRUG NAME: Ribociclib
DRUG NAME: Ribociclib SYNONYM(S): LEE011 1 COMMON TRADE NAME(S): KISQALI CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise adult provisions
More informationDRUG NAME: Vismodegib
DRUG NAME: Vismodegib SYNONYM(S): COMMON TRADE NAME(S): ERIVEDGE CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM OF
More informationDRUG NAME: Pomalidomide
DRUG NAME: Pomalidomide SYNONYM(S): COMMON TRADE NAME(S): POMALYST CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Olaparib SYNONYM(S): AZD-2281 1, KU-0059436, KU-59436 COMMON TRADE NAME(S): LYNPARZA CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise
More informationUSER'S GUIDE CANCER DRUG MANUAL DRUG MONOGRAPH: Updated: November 1, 2015
USER'S GUIDE Updated: November 1, 2015 The Cancer Drug Manual provides concise, evaluative drug information on drugs used in an oncology setting. The first edition of the Cancer Drug Manual was published
More informationEULEXIN PRODUCT INFORMATION NAME OF MEDICINE EULEXIN DESCRIPTION
EULEXIN PRODUCT INFORMATION NAME OF MEDICINE EULEXIN DESCRIPTION Each EULEXIN tablet contains 250 mg of flutamide, a non-steroidal, orally active antiandrogen. Each tablet also contains lactose anhydrous,
More informationDRUG NAME: Trastuzumab emtansine
DRUG NAME: Trastuzumab emtansine SYNONYM(S): T-DM1, trastuzumab-dm1, trastuzumab-mcc-dm1, ado-trastuzumab emtansine 1 COMMON TRADE NAME(S): KADCYLA CLASSIFICATION: miscellaneous Special pediatric considerations
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Olaparib SYNONYM(S): AZD-2281 1, KU-0059436, KU-59436 COMMON TRADE NAME(S): LYNPARZA CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise
More informationOral: readily and completely absorbed. Highly lipid soluble, present in breast milk. Volume of distribution % within 96 hours
Drug Monograph Drug Name Mechanism of Action and Pharmacokinetics Indications and Status Adverse ffects Dosing Administration Guidelines Special Precautions Interactions Recommended Clinical Monitoring
More informationReference ID:
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN (mitotane)
More informationAROMASIN 25mg (Tablets)
APPROVED PACKAGE INSERT AROMASIN SCHEDULING STATUS: S4 PROPRIETARY NAME AND DOSAGE FORM: AROMASIN 25mg (Tablets) COMPOSITION: Each sugar-coated tablet contains 25 mg exemestane. Preservative: methyl p-hydroxybenzoate
More informationData Sheet. BICALOX 50 mg is a white to off-white, round, film coated, biconvex tablets, engraved with 'BC 50' on one face and plain on the other.
BICALOX Data Sheet Bicalutamide 50 mg tablets Presentation BICALOX 50 mg is a white to off-white, round, film coated, biconvex tablets, engraved with 'BC 50' on one face and plain on the other. Uses Actions
More informationPROGESTINS AHFS 68:32
PROGESTINS AHFS 68:32 Class: Sex hormones. Indications: Hormone therapy in breast (megestrol), renal (medroxyprogesterone) and endometrial cancers, anorexia and cachexia (megestrol), postcastration hot
More informationDATA SHEET DP-ANASTROZOLE
Name of the Medicine DP-ANASTROZOLE Anastrozole 1 mg Film-coated Tablet. DATA SHEET DP-ANASTROZOLE Anastrozole 1 mg Film-coated Tablet Description Anastrozole is a benzyltriazole derivative. The chemical
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Lapatinib SYNONYM(S): lapatinib ditosylate monohydrate, 1 lapatinib tosylate, 2 GW572016 3 COMMON TRADE NAME(S): TYKERB CLASSIFICATION: miscellaneous Special pediatric considerations are noted
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Alectinib SYNONYM(S): CH5424802, RO5424802 1 COMMON TRADE NAME(S): ALECENSARO CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Avelumab SYNONYM(S): MSB0010718C 1 COMMON TRADE NAME(S): BAVENCIO CLASSIFICATION: monoclonal antibody Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
More informationDRUG NAME: Dabrafenib
DRUG NAME: Dabrafenib SYNONYM(S): dabrafenib mesylate 1, GSK2118436 2 COMMON TRADE NAME(S): TAFINLAR CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable,
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Nivolumab SYNONYM(S): COMMON TRADE NAME(S): OPDIVO CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM OF ACTION:
More informationDRUG NAME: Trametinib
DRUG NAME: Trametinib SYNONYM(S): Trametinib dimethyl sulfoxide, GSK1120212 1 COMMON TRADE NAME(S): MEKINIST CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise
More informationNew Zealand Datasheet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bicalutamide 50 mg film coated tablets
New Zealand Datasheet 1 PRODUCT NAME Binarex 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bicalutamide 50 mg film coated tablets 3 PHARMACEUTICAL FORM Binarex tablets are white to off-white, circular, biconvex,
More informationPACKAGE LEAFLET TEXT ZOLADEX LA 10.8MG. (goserelin)
ONC.000-092-861.10.0 PACKAGE LEAFLET TEXT ZOLADEX LA 10.8MG (goserelin) Name of the medicinal product Zoladex LA 10.8mg depot Qualitative and quantitative composition Goserelin acetate (equivalent to 10.8
More informationFor topical use only. Not for oral, ophthalmic, or intravaginal use.
DESOXIMETASONE Ointment USP, 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use. Rx only DESCRIPTION Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid
More informationClodronate BE/H/PSUR/001/001 October 2011 Agreed CSP
Clodronate BE/H/PSUR/001/001 October 2011 Agreed CSP 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Intravenous use Treatment of hypercalcemia due to malignancy. Oral use Treatment of hypercalcemia
More informationEmergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.
1. NAME OF THE MEDICINAL PRODUCT: Levonorgestrel Tablets 1.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains levonorgestrel 1.5 mg. Excipient with known effect: Each tablet contains
More informationMetopirone (metyrapone)
1 Metopirone (metyrapone) NAME OF THE DRUG Active ingredient: metyrapone Chemical names: 2-methyl-1,2-di-3-pyridyl-1-propanone CAS number: 54-36-4 Molecular weight: 226.27 Molecular formula C 14 H 14 N
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Ceritinib SYNONYM(S): LDK378 1 COMMON TRADE NAME(S): ZYKADIA CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise adult provisions
More informationMETOPIRONE Product Information
METOPIRONE Product Information (metyrapone) NAME OF THE MEDICINE Active ingredient: metyrapone Chemical name: 2-methyl-1,2-di-3-pyridyl-1-propanone Molecular formula: C14H14N2 O CAS number: 54-36-4 Molecular
More informationActive ingredients: Metoclopramide Hydrochloride mg Equivalent to metoclopramide hydrochloride anhydrous mg
Name Primperan 10 mg / 2 ml Metoclopramide hydrochloride anhydrous Solution for I.M. or I.V. injection (Ampoules) Composition Each 2 ml ampoule contains: Active ingredients: Metoclopramide Hydrochloride.
More information5. Summary of Data Reported and Evaluation
168 IARC MONOGRAPHS VOLUME 91 5. Summary of Data Reported and Evaluation 5.1 Exposure data The first oral hormonal contraceptives that were found to inhibit both ovulation and implantation were developed
More informationADVERSE REACTIONS The most common (>10%) adverse reactions are hypercalcemia, nausea, and diarrhea. (6.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PHOSLYRA safely and effectively. See full prescribing information for PHOSLYRA. PHOSLYRA (calcium
More informationDRUG NAME: Brentuximab vedotin
DRUG NAME: Brentuximab vedotin SYNONYM(S): SGN-35 1 COMMON TRADE NAME(S): ADCETRIS CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
More informationKELFER Capsules (Deferiprone)
Published on: 22 Sep 2014 KELFER Capsules (Deferiprone) Composition KELFER-250 Capsules Each capsule contains Deferiprone 250 mg KELFER-500 Capsules Each capsule contains Deferiprone 500 mg Dosage Form
More informationCOMPOSITION. A film coated tablet contains. Active ingredient: irbesartan 75 mg, 150 mg or 300 mg. Rotazar (Film coated tablets) Irbesartan
Rotazar (Film coated tablets) Irbesartan Rotazar 75 mg, 150 mg, 300 mg COMPOSITION A film coated tablet contains Active ingredient: irbesartan 75 mg, 150 mg or 300 mg. Rotazar 75 mg, 150 mg, 300 mg PHARMACOLOGICAL
More informationDraft Labeling Package Insert Not Actual Size. BRAINTREE LABORATORIES, INC. PhosLo Capsules (Calcium Acetate)
Draft Labeling Package Insert Not Actual Size BRAINTREE LABORATORIES, INC. PhosLo Capsules (Calcium Acetate) DESCRIPTION: Full Size: Each opaque capsule with a white cap and white body is spin printed
More informationM0BCore Safety Profile. Active substance: Triptorelin Pharmaceutical form(s)/strength: 0,1 mg P-RMS: DE/H/PSUR/0038/002 Date of FAR:
M0BCore Safety Profile Active substance: Triptorelin Pharmaceutical form(s)/strength: 0,1 mg P-RMS: DE/H/PSUR/0038/002 Date of FAR: 26.05.2014 4.3 Contraindications Hypersensitivity to GnRH, its analogues
More informationPRODUCT MONOGRAPH MEGESTROL. Megestrol Acetate Tablets USP. 40 mg and 160 mg. Progestogen / Antineoplastic / Antianorexic / Anticachectic
PRODUCT MONOGRAPH MEGESTROL Megestrol Acetate Tablets USP 40 mg and 160 mg Progestogen / Antineoplastic / Antianorexic / Anticachectic AA PHARMA INC. DATE OF REVISION: 1165 Creditstone Road, Unit #1 July
More informationSpironolactone has not been demonstrated to elevate serum uric acid, to precipitate gout or to alter carbohydrate metabolism.
SPIRONE Composition Each tablet contains Spironolactone 100 mg. Tablets Action Spironolactone is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors
More informationMetopirone. (Metyrapone Capsules) 250 mg
Metopirone (Metyrapone Capsules) 250 mg Diagnostic Test of Pituitary Adrenocorticotropic Function Rx only Prescribing Information DESCRIPTION Metopirone (metyrapone Capsules) 250 mg is an inhibitor of
More informationPRESCRIBING INFORMATION
PRESCRIBING INFORMATION pdp-pyrazinamide Pyrazinamide Tablets, USP 500 mg Antimycobacterial / Antituberculosis Agent PENDOPHARM, Division of Pharmascience Inc.. 6111, Royalmount Ave, Suite 100 Montréal,
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Nilotinib SYNONYM(S): nilotinib hydrochloride monohydrate 1 COMMON TRADE NAME(S): TASIGNA CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise
More informationDRUG NAME: Mechlorethamine
DRUG NAME: Mechlorethamine SYNONYM(S): Chlormethine, 1,2 HN 2, 3 Mustine, 3 Nitrogen Mustard 3 COMMON TRADE NAME(S): MUSTARGEN CLASSIFICATION: alkylating agent, 4 cytotoxic 5 Special pediatric considerations
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Ibrutinib SYNONYM(S): PCI-32765 1 COMMON TRADE NAME(S): IMBRUVICA CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
More informationDRUG NAME: Lenvatinib
DRUG NAME: Lenvatinib SYNONYM(S): E7080 1, ER 20349200 2, lenvatinib mesylate 2 COMMON TRADE NAME(S): LENVIMA CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when
More informationDRUG NAME: Temsirolimus
DRUG NAME: Temsirolimus SYNONYM(S): CCI-779 1 COMMON TRADE NAME(S): TORISEL CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM
More informationSUMMARY OF PRODUCT CHARACTERISTICS
MUTUAL RECOGNITION PROCEDURE Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT, syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of syrup contains 1 mg loratadine.
More informationPHARMACEUTICAL INFORMATION AZILSARTAN
AZEARLY Tablets Each Tablet Contains Azilsartan 20/40/80 mg PHARMACEUTICAL INFORMATION AZILSARTAN Generic name: Azilsartan Chemical name: 2-Ethoxy-1-{[2'-(5-oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl)-4-biphenylyl]methyl}-
More informationMODUS TABLETS. Medroxyprogesterone Tablets IP
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory MODUS TABLETS Medroxyprogesterone Tablets IP QUALITATIVE AND QUANTITATIVE COMPOSITION MODUS TABLET 2.5 mg Each uncoated
More informationBRLAACDT. Protocol Code. Breast. Tumour Group. Dr. Karen Gelmon. Contact Physician
BCCA Protocol Summary for Treatment of Locally Advanced Breast Cancer using DOXOrubicin and Cyclophosphamide followed by DOCEtaxel and Trastuzumab (HERCEPTIN) Protocol Code Tumour Group Contact Physician
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Comfora 595 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains: glucosamine sulphate
More informationARIMIDEX 1 mg Tablets ASTRAZENECA
10-14 ARIMIDEX 1 mg Tablets ASTRAZENECA anastrozole Tablet Composition Each tablet contains 1 mg anastrozole. For excipients see List of excipients. Pharmaceutical Form Film-coated tablet Therapeutic Indications
More informationCore Safety Profile. Pharmaceutical form(s)/strength: Immediate release tablets 1 mg, 2 mg, 4 mg and 8 mg (IR) Date of FAR:
Core Safety Profile Active substance: Doxazosin Pharmaceutical form(s)/strength: Immediate release tablets 1 mg, 2 mg, 4 mg and 8 mg (IR) P - RMS: DK/H/PSUR/0004/002 Date of FAR: 12.12.2011 4.3 Contraindications
More informationSpecial pediatric considerations are noted when applicable, otherwise adult provisions apply.
DRUG NAME: Porfimer SYNONYM(S): Dihaematoporphyrin ether, 1 porphyrins 2 COMMON TRADE NAME(S): PHOTOFRIN CLASSIFICATION: Miscellaneous Special pediatric considerations are noted when applicable, otherwise
More informationWARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS,
Celgene Corporation 86 Morris Avenue Summit, New Jersey 07901 Tel 908-673-9000 Fax 908-673-9001 October 2012 NEW Indication Announcement for ABRAXANE for Injectable Suspension (paclitaxel protein-bound
More informationBrand Name: Daliresp. Generic Name: roflumilast. Manufacturer: Forest Pharmaceuticals, Inc.
Brand Name: Daliresp Generic Name: roflumilast 3, 4, 5 Manufacturer: Forest Pharmaceuticals, Inc. 1, 2,4,5,7 Drug Class: Second Generation Phosphodiesterase 4 (PDE 4) inhibitor Labeled Uses: prophylaxis
More informationUMN request : information to be made public Page 1
Product Name Active substance Opdivo Nivolumab (BMS 936558) UMN request : information to be made public Page 1 Indication and conditions of use Nivolumab (Opdivo)) is registered by the EMA for the treatment
More informationRAYOS (prednisone tablet delayed release) oral tablet
RAYOS (prednisone tablet delayed release) oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan.
More informationCorticosteroids. Abdulmoein Al-Agha, FRCPCH Professor of Pediatric Endocrinology, King Abdulaziz University Hospital,
Corticosteroids Abdulmoein Al-Agha, FRCPCH Professor of Pediatric Endocrinology, King Abdulaziz University Hospital, http://aagha.kau.edu.sa History 1855 Addison's disease 1856 Adrenal glands essential
More informationKELFER Deferiprone. COMPOSITION KELFER-250 Capsules Each capsule contains Deferiprone 250 mg
KELFER Deferiprone COMPOSITION KELFER-250 Capsules Each capsule contains Deferiprone 250 mg KELFER-500 Capsules Each capsule contains Deferiprone 500 mg DOSAGE FORM Capsules PHARMACOLOGY Pharmacodynamics
More information5. Summary of Data Reported and Evaluation
326 5. Summary of Data Reported and Evaluation 5.1 Exposure data Combined estrogen progestogen menopausal therapy involves the co-administration of an estrogen and a progestogen to peri- or postmenopausal
More informationSANDOMIGRAN (pizotifen malate)
SANDOMIGRAN (pizotifen malate) S N CH 3 Pizotifen. COOH CH OH CH 2 COOH MALATE DESCRIPTION Pizotifen is a cycloheptathiophene derivative structurally related to cyproheptadine and the tricyclic antidepressants.
More informationNevirapine 200mg Tablet WHOPAR part 4 May 2005 Section 7 updated: May 2016 SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Nevirapine 200mg Tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nevirapine 200 mg. For excipients, see section
More information2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 PRODUCT NAME TROPISETRON-AFT tropisetron hydrochloride (equivalent to 2 mg or 5 mg tropisetron) per ampoule. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 1 mg of tropisetron 1 2 ml ampoule
More information2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT {To be completed nationally} 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mg tablets: each tablet contains 1 mg granisetron (as hydrochloride).
More information- 1 - PRODUCT INFORMATION. The chemical name for Lomustine is 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea with the structural formula:
- 1 - PRODUCT INFORMATION CeeNU (lomustine) APPROVED NAME Lomustine (CeeNU) DESCRIPTION Lomustine is an antitumour agent, cancer chemotherapeutic agent, cytotoxic agent and alkylating agent. Chemically,
More informationLACIPIL QUALITATIVE AND QUANTITATIVE COMPOSITION
LACIPIL lacidipine QUALITATIVE AND QUANTITATIVE COMPOSITION Lacidipine, 2 mg - round shaped white engraved on one face. Lacidipine, 4 mg - oval white with break line on both faces. Lacidipine, 6 mg - oval
More informationKEVEYIS (dichlorphenamide) tablets, for oral use Initial U.S. Approval: 1958
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEVEYIS safely and effectively. See full prescribing information for KEVEYIS. KEVEYIS (dichlorphenamide)
More informationPRODUCT MONOGRAPH CCP-ANASTROZOLE. (anastrozole) 1 mg tablet. Non-Steroidal Aromatase Inhibitor
PRODUCT MONOGRAPH Pr CCP-ANASTROZOLE (anastrozole) 1 mg tablet Non-Steroidal Aromatase Inhibitor CellChem Pharmaceuticals Inc., 30 Concourse Gate, Unit 1 Ottawa, Ontario K2E 7V7 Date of Revision: June
More informationPRODUCT MONOGRAPH. (anastrozole) 1 mg tablet. Professed Standard. Non-Steroidal Aromatase Inhibitor
PRODUCT MONOGRAPH Pr MINT-ANASTROZOLE (anastrozole) 1 mg tablet Professed Standard Non-Steroidal Aromatase Inhibitor Mint Pharmaceuticals Inc. 1093 Meyerside Drive, Unit 1 Mississauga, Ontario L5T 1J6
More informationAUSTRALIAN PRODUCT INFORMATION METOPIRONE (METYRAPONE) SOFT CAPSULE
AUSTRALIAN PRODUCT INFORMATION METOPIRONE (METYRAPONE) SOFT CAPSULE 1. NAME OF THE MEDICINE Metyrapone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Metopirone is supplied as soft gelatin capsules each containing
More informationORILISSA (elagolix) oral tablet
ORILISSA (elagolix) oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage
More informationBRAJACTT. Protocol Code. Breast. Tumour Group. Dr. Karen Gelmon. Contact Physician
BC Cancer Protocol Summary for Adjuvant Therapy for Breast Cancer using DOXOrubicin and Cyclophosphamide followed by PACLitaxel and Trastuzumab (HERCEPTIN) Protocol Code Tumour Group Contact Physician
More informationEmflaza. (deflazacort) New Product Slideshow
Emflaza (deflazacort) New Product Slideshow Introduction Brand name: Emflaza Generic name: Deflazacort Pharmacological class: Corticosteroid Strength and Formulation: 6mg, 18mg, 30mg, 36mg tablets; 22.75mg/mL
More informationM0BCore Safety Profile
M0BCore Safety Profile Active substance: Aciclovir Pharmaceutical form(s)/strength: Tablets 200, 400 or 800 mg Dispersible tablets 200, 400 or 800 mg Oral suspensions 200 mg or 400 mg per 5 ml. Freeze
More informationPRODUCT INFORMATION CODAPANE XTRA Paracetamol 500 mg and Codeine Phosphate 15 mg Tablets
PRODUCT INFORMATION CODAPANE XTRA Paracetamol 500 mg and Codeine Phosphate 15 mg Tablets NAME OF THE MEDICINE Active Ingredients: Paracetamol and Codeine Phosphate Paracetamol: Molecular Formula: C 8 H
More informationAPO-BICALUTAMIDE 50 MG TABLETS. (RS)-4'-Cyano-α, α, α ',-trifluoro-3-(4-fluorophenylsulphonyl)-2-hydroxy-2- methylpropiono-m-toluidide.
APO-BICALUTAMIDE 50 MG TABLETS NAME OF THE MEDICINE Bicalutamide Chemical Name: (RS)-4'-Cyano-α, α, α ',-trifluoro-3-(4-fluorophenylsulphonyl)-2-hydroxy-2- methylpropiono-m-toluidide. Structural Formula:
More information50 microgram/g Calcipotriol and 500 microgram/g betamethasone (as dipropionate).
DUPISOR Composition Gel 50 microgram/g Calcipotriol and 500 microgram/g betamethasone (as dipropionate). Action Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol
More informationNEW ZEALAND DATA SHEET
1. PRODUCT NAME Sudomyl, Tablet, 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Pseudoephedrine Hydrochloride 60mg Excipient(s) with known effect For the full
More informationALUNBRIG (brigatinib) Dosing Guide
ALUNBRIG (brigatinib) Dosing Guide INDICATION ALUNBRIG (brigatinib) is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
More informationDRUG NAME: Azacitidine
DRUG NAME: Azacitidine SYNONYM(S): ladakamycin 1 COMMON TRADE NAME(S): VIDAZA CLASSIFICATION: miscellaneous Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
More information